Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.

Duke University logo

Duke University

Status and phase

Completed
Phase 4

Conditions

Knee Extension
Primary Total Knee Arthroplasty
Pain
Knee Osteoarthritis
Physical Therapy

Treatments

Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block
Drug: Saline
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03353233
Pro00070573

Details and patient eligibility

About

The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • English speaking
  • Between 18 and 75 years old
  • American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty

Exclusion criteria

  • ASA 4 or 5
  • Revision knee arthroplasty
  • Diagnosis of chronic pain
  • Daily chronic opioid use (over 3 months of continuous opioid use)
  • Inability to communicate pain scores or need for analgesia
  • Acute knee dislocation/fracture
  • Infection at the site of block placement
  • Age under 18 years old or greater than 75 years old
  • Pregnant women
  • Intolerance/allergy to local anesthetics
  • Weight <50 kg
  • Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Trial design

50 participants in 2 patient groups, including a placebo group

iPACK Block Group
Experimental group
Description:
A nerve block technique using a numbing medication called ropivacaine.
Treatment:
Drug: Ropivacaine
Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block
Sham Group
Placebo Comparator group
Description:
The same nerve block technique as above, however using an inactive solution of salt water.
Treatment:
Drug: Saline
Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block

Trial documents
2

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems